Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone|
- Viral Load [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Adherence to ART [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Naltrexone Implant + ART
Naltrexone implant maintenance 48 weeks plus psychotherapy N=100
Drug: Naltrexone implant
Other Name: Prodetoxon implant
Active Comparator: ON Oral Naltrexone
ON (oral) naltrexone maintenance 48 weeks plus psychotherapy N=100
Drug: Oral naltrexone
Other Name: Revia
This is a double blind, double-dummy, placebo controlled, randomized trial of a 48-week course of implant naltrexone vs. oral naltrexone, each arm with drug counseling every two weeks, for 200 HIV+ patients who are in early remission from opioid dependence, as per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, and who are interested in relapse prevention treatment medication, and starting their first episode of antiretroviral therapy at the Botkin Infectious Disease Hospital in St. Petersburg or the Leningrad Regional AIDS Center. Early remission was chosen because relapse risk is the highest at this point (Woody & Cacciola, 1994), thus maximizing the chances for detecting a naltrexone effect. The first antiretroviral therapy treatment episode was chosen because it is feasible (relatively few opioid addicted Russians have been treated with antiretroviral therapy), and because the virus is less likely to have developed secondary resistance.
Patients will be recruited from the AIDS and addiction programs and those who meet study admission criteria will be stratified within each site according to baseline viral load (>100,000 copies/<100,000 copies) and CD4 count (>50/<50 copies). They will be randomized to a treatment condition, receive a naloxone challenge, and if they pass be prescribed oral naltrexone or oral placebo and implant/implant placebo), and given a schedule for their addiction counseling and HIV treatment appointments. A 2-week supply of oral medication will be provided at each bi-weekly counseling session, and they will be re-implanted at weeks 12, 24, and 36. Only the research pharmacist will know the group assignments, however the blind can be broken in case of emergency.
The primary outcome measure will be to compare implanted naltrexone versus oral naltrexone on ability to achieve a viral load of <400 copies at weeks 24 and 48.
Secondary outcomes are to compare the efficacy of the two addiction treatments; to study the adherence to antiretroviral therapy; to evaluate time to relapse and the number of days to relapsed; to evaluate decline in CD4 counts; to evaluate HIV risk behavior; to evaluate opioid positive urine tests; and to evaluate the number of days that patients will keep their scheduled appointments. We will also monitor psychiatric symptoms, other drug use, and overall adjustment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02046252
|Botkin Infectious Disease Hospital|
|Leningrad, Russian Federation|
|Principal Investigator:||George E Woody, MD||University of Pennsylvania|